ICOUGH Bundle and Postoperative Pain and Nausea After Laparoscopic Cholecystectomy

NCT ID: NCT06755970

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-01

Brief Summary

This study will use a randomized controlled experimental research design. The population of the study will consist of all adult patients who undergo laparoscopic cholecystectomy at the General Surgery Clinic of Atatürk University Research Hospital between December 2024 and September 2025. The data will be collected using a Descriptive Information Form and the Visual Analogue Scale. The research has received institutional approval and ethics committee approval. The study will be conducted with collaboration from healthcare professionals in the clinic after they have been informed. Patients who meet the inclusion criteria will be invited to participate in the study after being approached one day before surgery. Oral and written consent will be obtained from those who volunteer and agree to participate. The data will be analyzed using SPSS for Windows 22 software.

Detailed Description

Post-laparoscopic cholecystectomy, patients may experience pain at the incision site, internal organ pain, and shoulder pain. Shoulder pain occurs due to the irritation of the diaphragm peritoneum by dissolved CO2 gas, causing the diaphragm to stretch, which stimulates the phrenic nerve and results in shoulder pain in these patients. This shoulder pain is typically felt up to 72 hours or three days after surgery.

Shoulder pain in these patients is typically felt for up to 72 hours or three days after surgery. Pneumoperitoneum during laparoscopy can also produce vagal stimulation, which can lead to nausea and vomiting. In this context, the removal of CO2 is essential for managing post-laparoscopic cholecystectomy CO2-related pain.

Given the relatively common and costly occurrence of postoperative respiratory complications, various protocols have been used to reduce the risk of these complications. One such protocol is the ICOUGH (Incentive spirometry, Coughing and deep breathing, Oral care, Patient understanding of the interventions, Getting out of bed and Head of bed elevation) bundle, developed by the Boston University School of Medicine in 2012 to reduce postoperative respiratory complications. This respiratory care bundle improves oxygenation and CO2 elimination, thus increasing the patient's recovery rate, reducing the amount of analgesics used, and shortening the time to return to daily activities.

The ICOUGH bundle, which is among the important independent responsibilities of perioperative nurses, helps reduce shoulder pain and accelerate postoperative recovery by increasing CO2 elimination and oxygenation. The use of non-pharmacological methods for pain relief in the postoperative period strengthens the nurse's role in pain management. The aim of this study is to determine the effects of the ICOUGH bundle on shoulder pain, abdominal pain, and nausea after laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy; Pain; ICOUGH; NAUSEA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Grup 1

The ICOUGH care bundle will be applied to this group.

Group Type: EXPERIMENTAL

ICOUGH

Intervention Type: PROCEDURE

After the patient has recovered from postoperative anesthesia and their hemodynamic values have stabilized, the ICOUGH bundle applications mentioned above will be carried out. The patient's pain and nausea levels will be recorded for a period of 48 hours.

Postoperative pain and nausea will be assessed with the help of data collectors, using a numerical rating scale at 2, 4, 8, 12, 24, and 48 hours after surgery.

Considering that postoperative respiratory complications are relatively common and costly, various studies have been conducted to explore ways to reduce the risk of their occurrence. One of these protocols is the ICOUGH bundle, which stands for Incentive Spirometry, Coughing and Deep Breathing, Oral Care, Patient Understanding of the Interventions, Getting Out of Bed, and Head of Bed Elevation.

Control grup: Grup 2

The ICOUGH care bundle will not be applied to this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICOUGH

After the patient has recovered from postoperative anesthesia and their hemodynamic values have stabilized, the ICOUGH bundle applications mentioned above will be carried out. The patient's pain and nausea levels will be recorded for a period of 48 hours.

Postoperative pain and nausea will be assessed with the help of data collectors, using a numerical rating scale at 2, 4, 8, 12, 24, and 48 hours after surgery.

Considering that postoperative respiratory complications are relatively common and costly, various studies have been conducted to explore ways to reduce the risk of their occurrence. One of these protocols is the ICOUGH bundle, which stands for Incentive Spirometry, Coughing and Deep Breathing, Oral Care, Patient Understanding of the Interventions, Getting Out of Bed, and Head of Bed Elevation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Those who agree to participate in the study and volunteer
• Aged 18 and above
• Undergoing laparoscopic cholecystectomy surgery under general anesthesia
• Those without physical or mental disabilities, limitations, or conditions that would prevent them from performing respiratory exercises (such as the use of medications affecting respiration, conditions requiring oxygen therapy, etc.)
• Those whose cognitive level is suitable for the application of scales
• Patients without communication problems will be included in the study

Exclusion Criteria

• Those whose hemodynamic values are not stable after the surgical intervention
• Those who develop any complications such as severe bleeding, nausea, vomiting, etc., after surgery
• Patients with acute or chronic lung diseases
• Patients who voluntarily wish to withdraw from the study will not be included in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

MERVE KAYA

pricipal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

MERVE KAYA

Role: CONTACT

merve.bagdigen@atauni.edu.tr

05313748304 ext. 0531 374 83 04

Other Identifiers

AtaturkUnıversty

Identifier Type: -

Identifier Source: org_study_id